BEUDAMED
    FDA Enforcement Class II Terminated

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    Recall: Z-1669-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1669-2016
    Event ID
    73765
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lumenis Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2016
    Initiation Date
    November 17, 2015
    Classification Date
    May 13, 2016
    Termination Date
    November 30, 2016
    Address
    13 Hayetzira St.,Yokneam Ind. Park, N/A, Yokneam, N/A, N/A, Israel

    Description

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    Reason

    Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.

    Code Info

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) All Acne Filters manufactured and Distributed Between: August 04 2015 and November 06 2015

    Distribution

    Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.

    Quantity

    33 filters